The current FDA approval of Kymriah is based on data from the Phase 2 ELARA trial in which 68% of patients experienced a complete response, with an 86% overall response rate, along with a superior safety profile

facing-banting-1-novartis-campus-basel

Novartis Campus Banting 1 laboratory. (Credit: Novartis AG)

Novartis has received the US Food and Drug Administration (FDA) accelerated approval for Kymriah (tisagenlecleucel) to treat follicular lymphoma (FL).

Approved under FDA’s accelerated approval program, the drug is indicated for adult patients with relapsed or refractory (r/r) FL, after two or more lines of systemic therapy.

Kymriah has already been approved by the US FDA in three indications and is the only CAR-T cell therapy approved in both adult and paediatric settings, said Novartis.

Earlier this month, the drug has been in the European Union (EU) to treat adult patients with r/r FL after two or more lines of systemic therapy, which forms its third indication in the EU.

The continued approval for the drug, in this indication may be subject to verification of its clinical benefit in a confirmatory trial, said the Swiss drugmaker.

Novartis US innovative medicines president Victor Bulto said: “We are proud of today’s FDA approval of the third indication for Kymriah.

“We hope this treatment option that has the potential for long-lasting results may help break the unrelenting cycle of treatment for patients with follicular lymphoma.

“We are on a mission to build on our pioneering work in cell therapy and continue to innovate for patient impact.”

The FDA approval is based on data from the Phase 2 ELARA trial which evaluated the efficacy of Kymriah in 90 study participants and showed a superior safety profile.

In the study, 26% of patients treated with Kymriah achieved a response, of which around 68% of participants experienced a complete response.

Among patients who achieved a complete response, around 85% of patients are estimated to demonstrate a prolonged durable response to the treatment.

Kymriah will be effective in high-risk patients including those who had refractory disease, POD24, bulky disease, or with high Follicular Lymphoma International Prognostic Index (FLIPI) scores, said the company.

Trial principal investigator Stephen Schuster said: “Patients with follicular lymphoma who relapse or don’t respond to treatment have a poor prognosis and may face a series of treatment options without a meaningful, lasting response.

“This new, effective option for patients with follicular lymphoma may offer long-term benefit.”